drugset / Trial / NCT07795203

Liposomal Bupivacaine vs Ropivacaine for Post-hemorrhoidectomy Analgesia

NCT07795203 ↗

Phase 4 Not yet recruiting 140 enrolled Tongliao City People's Hospital
RandomizedSequentialOpen-labelTreatment

Summary

This is a single-center, prospective, randomized, double-blind controlled trial comparing the analgesic efficacy, quality of recovery, and safety of perianal wound infiltration with multivesicular liposomal bupivacaine (266 mg) versus ropivacaine hydrochloride (200 mg) in patients undergoing Milligan-Morgan open hemorrhoidectomy under spinal anesthesia. Both solutions are diluted to a total volume of 30 mL and infiltrated at six predefined perianal positions at the end of surgery. The primary outcome is the resting visual analog scale (VAS) pain score at 24 hours after surgery. Secondary outcomes include resting and movement-evoked VAS pain scores at 4, 6, 12, 24, and 48 hours, cumulative rescue analgesic consumption during postoperative days 1-3, Quality of Recovery-40 (QoR-40) scores on postoperative days 1-3, and adverse events within 72 hours after surgery.

Timeline

Start
2026-08-30
Primary completion
2027-09-01
Completion
2027-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 266 mg Other
Comparator Ropivacaine Other / unclassified 200 mg Other

Indications

No indication recorded.